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Clinical Trials in Canada / NCT06386003
Recruiting Phase 2

Psilocybin-Assisted Cognitive Processing Therapy for Chronic PTSD

NCT06386003 · tracked via the Priya Life Science Canada tracker
Phase
Phase 2
Started
2026-06
Last updated
2026-06-26

Condition(s) studied

Post Traumatic Stress DisorderPTSDChronic PTSD

Investigational drug(s) / intervention(s)

Psilocybin →

Psilocybin: Participants will receive a single dose of psilocybin 25mg combined with 12 sessions of massed CPT, and 2 psychotherapy sessions related to psilocybin over 7 days.

Study summary

This is an open-label trial evaluating feasibility, tolerability, safety and efficacy of psilocybin assisted cognitive processing therapy for chronic Posttraumatic Stress Disorder (PTSD).

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: 1. Meet Diagnostic and Statistical Manual-5th edition (DSM-5) criteria for current PTSD with a duration of 6 months or longer assessed by study psychiatrist; 2. Have a Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) score of 50 or higher, indicating moderate to severe PTSD symptoms; 3. Are willing to refrain from taking any psychiatric medications during the study period. Exclusion Criteria: 1. Are pregnant or nursing, or are women of child bearing potential who are not practicing an effective means of birth control; 2. Have a history of or a current primary diagnosis of psychotic disorder, schizophrenia, delusional disorder, borderline personality disorder, schizoaffective disorder, bipolar disorder or, dissociative identity disorder; 3. Have evidence or history of coronary artery disease or cerebral or peripheral vascular disease, hepatic disease with abnormal liver enzymes, or any other medical disorder judged by the investigator to significantly increase the risk of psilocybin administration; 4. Have hypertension using the standard criteria of the American Heart Association (values of 140/90 or higher assessed on three separate occasions; 5. History of seizure disorder; 6. Uncontrolled insulin-dependent diabetes; 7. Recent stroke, intracranial or subarachnoid hemorrhage (\< 1 year from signing of informed consent form \[ICF\]), recent myocardial infarction (\< 1 year from signing of ICF), clinically significant arrhythmia (\< 1 year from signing of ICF); 8. Have liver disease with the exception of asymptomatic subjects with Hepatitis C who have previously undergone evaluation and successful treatment; 9. Lifetime history of substance-induced psychosis; 10. Lifetime history of substance use disorder with a hallucinogen; 11. History of alcohol use disorder in the past 3 months.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
St. Michael's Hospital, Unity Health Toronto Toronto Ontario Recruiting

More Unity Health Toronto trials in Canada

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06386003 on ClinicalTrials.gov ↗ ← All trials in Canada